Probiotics to help non-organic digestive problems

Study on the Effect of Probiotics on Improving Gastrointestinal Function in Patients With Non-organic Gastrointestinal Dysfunction

This trial will test whether four weeks of a compound probiotic can improve gastrointestinal function in adults (18–65) with non-organic digestive disorders.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (industry)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07081100 on ClinicalTrials.gov

What this trial studies

This interventional study gives adults with clinically diagnosed non-organic gastrointestinal dysfunction a compound probiotic for four weeks and measures changes in gastrointestinal function. Participants must be 18–65 and free of serious organic disease; common examples include functional dyspepsia and functional constipation. Key exclusions include recent or ongoing antibiotic or probiotic use, pregnancy, allergy to the product, and severe systemic illness. The trial is sponsored by Wecare Probiotics and conducted at Suzhou Ninth Hospital affiliated to Soochow University.

Who should consider this trial

Good fit: Adults aged 18–65 with a clinical diagnosis of non-organic gastrointestinal dysfunction, able to give consent and follow the protocol, and not recently using antibiotics or similar products are ideal candidates.

Not a fit: People with organic gastrointestinal disease, recent or ongoing antibiotic use, allergy to the product, pregnancy or severe systemic illness are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the probiotic course could reduce symptoms and improve bowel function for people with functional gastrointestinal disorders.

How similar studies have performed: Previous trials of probiotics for functional gastrointestinal disorders have produced mixed results, with some strains showing modest symptom improvement while others show little effect.

Eligibility criteria

Inclusion Criteria:

* Voluntarily sign the informed consent form and agree to participate in the study.
* Ability to complete the study according to the trial protocol requirements.
* Aged 18-65 years.
* Clinical diagnosis of non-organic gastrointestinal dysfunction (e.g., functional dyspepsia, functional constipation) without other serious organic diseases.

Exclusion Criteria:

* Use of drugs affecting intestinal flora (antibiotics, probiotics, intestinal mucosal protectants, herbal medicines, etc.) for \>1 week within 1 month prior to screening.
* Short-term use of products with functions similar to the investigational product, which may interfere with result interpretation.
* Antibiotic use during the study period.
* History of severe systemic diseases or malignancies.
* Allergy to any ingredient in the compound probiotic freeze-dried powder used in the trial.
* Pregnancy, lactation, or plans for pregnancy in the near future.
* Inability to participate due to personal reasons.
* Other conditions deemed unsuitable by the investigators.

Where this trial is running

Suzhou, Jiangsu

• Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Ying Jin, Doctor

Conditions: Gastrointestinal Function